FDA applicant

Hpi, Inc.

Newton Centre, MA6 decisions1990–19930 recalls

FDA records 6 decisions for Hpi, Inc. (Newton Centre, MA) from 1990 to 1993: 6 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and IWP (Radiographic Protective Glove). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Hpi, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hpi, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hpi, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Hpi, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?